ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD— 510(k) K103615

Clearance details

Applicant

Alfa Wassermann Diagnostic Technologies, Inc.

Product code

Code CDN

Device class

Class 2

Regulation

21 CFR 862.1770

Advisory panel

Clinical Chemistry

Date received

2010-12-09

Decision date

2011-09-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Caldwell, NJ, US

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• Z-0743-2013 — Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.Class II·Terminated·Alfa Wassermann, Inc.·20121010

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103615.